FDA 510(k) Applications Submitted by SPECTRAL DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K992127 |
06/23/1999 |
CARDIOQUANT TROPONIN I TEST |
SPECTRAL DIAGNOSTICS, INC. |
| K972408 |
06/26/1997 |
CARDIAC STATUS CONTROLS |
SPECTRAL DIAGNOSTICS, INC. |
| K972687 |
07/17/1997 |
CARDIAC STATUS CONTROLS/TROPONIN I |
SPECTRAL DIAGNOSTICS, INC. |
| K982679 |
07/31/1998 |
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST |
SPECTRAL DIAGNOSTICS, INC. |
| K981474 |
04/24/1998 |
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) |
SPECTRAL DIAGNOSTICS, INC. |
| K991447 |
04/26/1999 |
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS |
SPECTRAL DIAGNOSTICS, INC. |
| K020950 |
03/25/2002 |
SPECTRAL'S 2 IN 1 (TNI-MYO) |
SPECTRAL DIAGNOSTICS, INC. |
| K030057 |
01/07/2003 |
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST |
SPECTRAL DIAGNOSTICS, INC. |
| K022409 |
07/24/2002 |
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST |
SPECTRAL DIAGNOSTICS, INC. |
| K052519 |
09/14/2005 |
SPECTRAL WEST NILE VIRUS IGM STATUS TEST |
SPECTRAL DIAGNOSTICS, INC. |
| K014105 |
12/13/2001 |
SPECTRAL'S TROPONIN I |
SPECTRAL DIAGNOSTICS, INC. |
| DEN030002 |
04/14/2003 |
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
SPECTRAL DIAGNOSTICS, INC. |
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